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Two Phase 3 clinical trials were reviewed to support efficacy (Studies ST-601A-002a and ST-601A-002b) and seven studies were reviewed to support safety.

The efficacy studies (Studies 002a and 002b) were double-masked, randomized, placebo-controlled clinical trials evaluating ST-601 in the treatment of inflammation and pain following ocular surgery.

Each study was conducted under an identical but separate protocol.

As specified in the protocol and the Statistical Analysis Plan, the analysis was to be conducted strictly geographically, with sites located north of latitude 37° in Study 002b and sites located south of latitude 37° in Study 002a.

In each study, the efficacy and safety of ST-601, dosed either BID or QID for 14 days, was compared with vehicle in subjects who had undergone unilateral ocular surgery.

On Day 15, after completion of the planned treatment course, subjects who had an anterior chamber cell grade of “0” (defined as ≤1 cell) or who had responded satisfactorily to treatment as judged by the investigator began graduated tapering of the study drug, which successively halved the number of doses per day at each step.

Safety/Intent to Treat (ITT) population-All randomized subjects that received at least 1 dose of the study drug. Subjects were analyzed according to the treatment they were assigned to at randomization, irrespective of compliance or any deviations from the study protocol.

Per Protocol (PP) population-All randomized subjects who had no protocol violations (i.e. subjects who complied with the protocol sufficiently to ensure that the data exhibited the effects of the active substance when administered as intended). According to the study protocol, the term “protocol violations” denoted those deviations from the protocol that led to the exclusion of the subject from the PP analysis, while “protocol deviations” subsumed minor deviations that had no impact on the PP analyses. Protocol violations included violation of entry criteria, lack of compliance, and the use of prohibited medications.

The primary efficacy endpoint for Studies 002a and 002b was the proportion of subjects with an anterior chamber cell grade of “0” on Day 8 as compared between the ST-601 QID and placebo groups.

Since the Agency considers that a clinically meaningful endpoint would be complete clearing of anterior chamber cells where a grade 0=0 cells in the anterior chamber, the Agency utilized complete clearing of anterior chamber cells where a grade 0=0 cells in the anterior chamber in our efficacy determinations.